FDA Approves First-Ever Smallpox Drug As A Precaution Against Bioterrorism

In the event of a bioterrorist attack, the smallpox vaccine that eradicated the disease 40 years ago would be too dangerous to give to everyone.

The U.S. Food and Drug Administration (FDA) has just green-lighted a drug for a disease that’s been eradicated since 1980. TPOXX (tecovirimat) is now the world’s first drug designed to treat smallpox and was approved on July 13, according to an announcement by the FDA.

Although the devastating disease hasn’t resurfaced in 40 years, the FDA has its reasons for approving the new drug. The move stems from concerns that the variola virus (pictured above) which causes this contagious and sometimes fatal disease may end up being used as a bioweapon.

“To address the risk of bioterrorism, Congress has taken steps to enable the development and approval of countermeasures to thwart pathogens that could be employed as weapons,” FDA commissioner Dr. Scott Gottlieb said in a statement on Friday.

“Today’s approval provides an important milestone in these efforts. This new treatment affords us an additional option should smallpox ever be used as a bioweapon,” Gottlieb pointed out.

While smallpox was declared eradicated by the World Health Organization after a global vaccination campaign — meaning it no longer occurs naturally, explains Live Science — the disease still exists in the world, safeguarded in laboratory freezers for research purposes.

The only two facilities known to still have samples of the smallpox virus are the Centers for Disease Control and Prevention (CDC) in Atlanta and the Russian State Centre for Research on Virology and Biotechnology in Siberia.

But bioterrorism experts are worried that more samples of the virus might still be out there — after all, in 2014 the National Institutes of Health stumbled upon six sealed vials of smallpox that no one knew were still there, notes the New York Times.

A more worrisome hypothesis is that the smallpox virus could potentially be rebuilt in the lab — as was the case last year with the smallpox-related horsepox virus, which showed that this type of viruses can be recreated from DNA fragments — and released back again into the world, either by accident or intentionally.

“There is credible concern that in the past some countries made the virus into weapons, which may have fallen into the hands of terrorists or other people with criminal intentions,” points out the CDC.

In the event of a bioterrorist attack, everyone under the age of 40 would be vulnerable to the disease — which causes puss-filled sores to appear on the body, as well as fever, headache, and exhaustion, and could lead to complications such as encephalitis (inflammation of the brain), open sores on the cornea of the eye, and blindness.

The already existing smallpox vaccine could only be used to protect a limited number of the population. This is because the vaccine is too dangerous to be administered to everyone and would leave pregnant women, cancer patients, people with eczema and a few other skin conditions, and anyone suffering from an immunosuppressive disease unprotected against smallpox.

To err on the side of caution and prevent a potentially lethal pandemic, as the disease spreads from person to person through direct contact, the FDA has now approved the first-ever smallpox drug.

Manufactured by SIGA Technologies, an Oregon pharmaceutical company with research in the biodefense arena, TPOXX proved effective in animal studies conducted on viruses that are closely related to smallpox.

According to the FDA, these studies were performed under the Animal Rule, which allows animal studies to be used to support approval “when it is not feasible or ethical to conduct efficacy trials in humans.”

The drug’s safety was also assessed on almost 360 people not infected with smallpox and who volunteered for the tecovirimat test.

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